Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed to measure serum and salivary CYFRA21-1 levels using enzyme linked immunosorbent assay (ELISA) in patients with oral malignancy, oral potentially malignant lesions, and control subjects to evaluate the potential of CYFRA21-1 as a diagnostic marker for malignant transformation in potentially malignant oral mucosal lesions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | participants suffering from oral potentially malignant lesions |
| |
| Group II | participants suffering from diagnosed oral malignant lesions |
| |
| Group III | healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzyme Linked Immunosorbent assay (ELISA) | Diagnostic Test | measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA) |
| Measure | Description | Time Frame |
|---|---|---|
| sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer | diagnostic accuracy in terms of sensitivity and specificity of serum and salivary CYFRA21-1 in differentiating between oral malignancy and oral potential malignant lesions in order to be able to early diagnose malignant changes in oral lesions. | one year |
Not provided
Not provided
Inclusion Criteria:
participants will be divided into 3 groups:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Egyptian population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salsabeel A Mahmoud | Contact | 00201222343488 | salsabeel_ali@hotmail.com | |
| Basma A Zakaria | Contact | basma.abdelalim@dentistry.cu.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24304502 | Background | Rajkumar K, Ramya R, Nandhini G, Rajashree P, Ramesh Kumar A, Nirmala Anandan S. Salivary and serum level of CYFRA 21-1 in oral precancer and oral squamous cell carcinoma. Oral Dis. 2015 Jan;21(1):90-6. doi: 10.1111/odi.12216. Epub 2013 Dec 30. | |
| 20651382 | Background | Alkotyfan K, Wiegand S, Muller HH, Windfuhr JP, Werner JA, Sesterhenn AM. Cyfra 21-1 as a tumor marker for follow-up of patients with squamous cell carcinoma of the oropharynx. Anticancer Res. 2010 Jun;30(6):2291-6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 29323056 | Background | Awasthi N. Role of salivary biomarkers in early detection of oral squamous cell carcinoma. Indian J Pathol Microbiol. 2017 Oct-Dec;60(4):464-468. doi: 10.4103/IJPM.IJPM_140_16. |
| 26577643 | Background | Gualtero DF, Suarez Castillo A. Biomarkers in saliva for the detection of oral squamous cell carcinoma and their potential use for early diagnosis: a systematic review. Acta Odontol Scand. 2016;74(3):170-7. doi: 10.3109/00016357.2015.1110249. Epub 2015 Nov 18. |
| 26779624 | Background | Malhotra R, Urs AB, Chakravarti A, Kumar S, Gupta VK, Mahajan B. Correlation of Cyfra 21-1 levels in saliva and serum with CK19 mRNA expression in oral squamous cell carcinoma. Tumour Biol. 2016 Jul;37(7):9263-71. doi: 10.1007/s13277-016-4809-4. Epub 2016 Jan 15. |
| 25024833 | Background | Mortazavi H, Baharvand M, Mehdipour M. Oral potentially malignant disorders: an overview of more than 20 entities. J Dent Res Dent Clin Dent Prospects. 2014 Winter;8(1):6-14. doi: 10.5681/joddd.2014.002. Epub 2014 Mar 5. |
| 24065233 | Background | Wang YX, Hu D, Yan X. Diagnostic accuracy of Cyfra 21-1 for head and neck squamous cell carcinoma: a meta-analysis. Eur Rev Med Pharmacol Sci. 2013 Sep;17(17):2383-9. |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided